Testing When Initiating and During Treatment with BIKTARVY

Prior to or when initiating BIKTARVY, test patients for hepatitis B virus infection [see Warnings and Precautions (5.1)].

Prior to or when initiating BIKTARVY, and during treatment with BIKTARVY, assess serum creatinine, estimated creatinine clearance, urine glucose and urine protein in all patients as clinically appropriate. In patients with chronic kidney disease, also assess serum phosphorus [see Warnings and Precautions (5.4)].

Recommended Dosage in Adults and Pediatric Patients Weighing at Least 25 kg

BIKTARVY is a three-drug fixed dose combination product containing bictegravir (BIC), emtricitabine (FTC), and tenofovir alafenamide (TAF). The recommended dosage of BIKTARVY is one tablet containing 50 mg of BIC, 200 mg of FTC, and 25 mg of TAF taken orally once daily with or without food in:

• adults and pediatric patients weighing at least 25 kg with an estimated creatinine clearance greater than or equal to 30 mL/min; or
• virologically-suppressed adults with an estimated creatinine clearance below 15 mL/min who are receiving chronic hemodialysis. On days of hemodialysis, administer the daily dose of BIKTARVY after completion of hemodialysis treatment [see Use in Specific Populations (8.4, 8.6) and Clinical Pharmacology (12.3)].

Recommended Dosage in Pediatric Patients Weighing at Least 14 kg to Less than 25 kg

The recommended dosage of BIKTARVY is one tablet containing 30 mg of BIC, 120 mg of FTC, and 15 mg of TAF taken orally once daily with or without food in:

• pediatric patients weighing at least 14 kg to less than 25 kg with an estimated creatinine clearance greater than or equal to 30 mL/min [see Use in Specific Populations (8.4, 8.6) and Clinical Pharmacology (12.3)].

For children unable to swallow a whole tablet, the tablet can be split and each part taken separately as long as all parts are ingested within approximately 10 minutes.

Not Recommended in Patients with Severe Renal Impairment

BIKTARVY is not recommended in patients with [see Dosage and Administration (2.2, 2.3) and Use in Specific Populations (8.6)].:

• severe renal impairment (estimated creatinine clearance of 15 to below 30 mL/min); or
• end stage renal disease (ESRD; estimated creatinine clearance below 15 mL/min who are not receiving chronic hemodialysis; or
• no antiretroviral treatment history and ESRD who are receiving chronic hemodialysis.

Not Recommended in Patients with Severe Hepatic Impairment

BIKTARVY is not recommended in patients with severe hepatic impairment (Child-Pugh Class C) [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].